Kornimate/medical-research-clean huggingface dataset:
mini-hysteroscopy versus conventional office hysteroscopy in nulliparous patients undergoing office hysteroscopy

Conditions: Pain

Summary: the aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.

the results of the studies comparing the pain experienced by the patients undergoing conventional office hysteroscopy or mini-hysteroscopy were mixed. several studies revealed that mini-hysteroscopy significantly reduced the procedure related pain and other studies revealed that the use of mini-hysteroscope was not associated with significant reduction in the procedure related pain. the aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.

Eligibility criteria:
inclusion criteria: * nulliparous patients exclusion criteria: * parous patients, menopausal status, cervical pathology, and previous cervical surgery

Keywords: mini-hysteroscopy office hysteroscopy pain
safety and immunogenicity following meningococcal and pneumococcal immunization among adult people living with hiv

Conditions: Hiv; Meningococcal Infections; Pneumococcal Infections

Summary: menpi is an investigator-initiated single-centre randomized controlled trial which aims to assess the efficacy and safety of meningococcal and pneumococcal vaccination in adults living with hiv receiving antiretroviral treatment. participants are randomized 1:1 to either a two-dose menveo® and bexsero® regimen or a prevenar13®/pneumovax23® prime-boost regimen at day 0 and day 60 and cross over on day 90. all participants will follow an identical follow up program including plasma collection, pharyngeal swab, and adverse event registration. immunogenicity will be determined on venous blood sampled at 30 days post-vaccination and yearly for five years.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * seropositive for hiv-1 * recipient of art * plasma hiv-rna \< 500 copies/ml * patients written consent obtained exclusion criteria: * pregnancy or breastfeeding * history of meningococcal or pneumococcal vaccination * allergies towards any of the vaccine components * temperature \> 38 ᵒc * sign of bacterial infection * previous known or suspected disease caused by n. meningitidis * active aids associated illness * active malignancy * end-stage renal or liver disease * bleeding disorder * recipient of any blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within the last month * use of immunosuppressive agents (corticosteroids, cancer chemotherapeutic agents etc.)
evaluation of fiit-ns® in health-related quality of life improvement in overweight and obese subjects

Conditions: Overweight and Obesity

Summary: the purpose of this study is to evaluate the effects of a 16-week supplementation with a polyphenol-rich extract, fiit-ns®, on improvement of health-related quality of life (hr-qol) of overweight and obese volunteers, as compared to placebo. previous beneficial results from a pilot study showed that the supplementation may improve quality of life as well as body composition. based on such results, this pivotal study is statistically powered to detect significant differences in hr-qol assessed with the short form-36 health survey (sf-36) between baseline (week 1, w1) and end of the supplementation period (week 16, w16).


Eligibility criteria:
inclusion criteria: * 25 kg/m2 ≤ body mass index (bmi) ≤ 40 kg/m2 * 25-55 years old exclusion criteria: * metabolic and/or chronic disease (diabetes, dyslipidemia, thyroiditis, inflammatory disease, immunological disease, asthma, anxiety, depression) * allergy to one of the ingredients of the supplement * current involvement of involvement within the 6 previous months in a chronic supplement program, chronic treatment program, weight loss program * smoking cessation * high alcohol consumption * pregnancy * breastfeeding * menopausal women * involvement in physical activity more than twice a week
the study of efficacy and safety of a 60-day use of the magnox comfort compared to the placebo in subjects with nlc

Conditions: Nocturnal Leg Cramps

Summary: a randomized, multicenter, prospective, double-blind, placebo-controlled, clinical trial in the parallel groups to determine the efficacy and safety of a 60-day use of the dietary supplement magnox comfort compared to the placebo in subjects with nocturnal legs cramps

at the beginning of the study, study subjects undergo a 14-day screening period during which the number of episodes of nlc is recorded. for further participation in the study, they must have at least 4 nlc episodes. thereafter, an examination of compliance with the study requirements is performed and study subjects are randomized to one of the two groups: for a 60-day of ip use (1 capsule of magnox comfort daily) or to the control group (1 capsule of placebo daily).

Eligibility criteria:
inclusion criteria: 1. the study subject is informed and he/she was given enough time to think on his participation in the study and signed the informed consent form before the beginning of any procedures; 2. a study subject is a man or a woman over the age of 45 years; 3. the study subject has an established diagnosis of the nocturnal legs cramps; 4. the study subject understands the ukrainian language; 5. the study subject has satisfactory results of the neurological examination of both lower extremities; 6. the study subject has a telephone and can use it permanently; exclusion criteria: 1. the onset of one of the non-inclusion criteria; 2. the study subject has less than 4 episodes of nlc during the 14-day screening period; 3. there is necessity for significant change in the treatment tactics.

Keywords: nocturnal legs cramps legs cramps nlc
tuberculosis (tb) immunotherapy phase 2 study

Conditions: Tuberculosis

Summary: this is a phase ii, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of v7 in combination with standard of care anti-tuberculosis (tb) therapy (att) among mycobacterium tuberculosis-infected sputum smear positive subjects. the results will be compared to placebo combined with standard att therapy. the trial will consist of one stage with sputum evaluation at months 1 and 2.


Eligibility criteria:
inclusion criteria: * subjects who are at least 18 years old and are willing and capable of providing informed consent. both men and non-pregnant women will be included. * tb infection documented prior to study entry by sputum smear positive for acid-fast bacilli (afb) test. * tb score status at baseline. * agreement to participate in the study and to give a sample of blood for lab testing. * readily available home or other address where patient can be found. exclusion criteria: * subjects who might have already taken v5 in prior trial and have no baseline data. pregnant or breast-feeding women are excluded. * subjects who have taken study unrelated drugs or immunomodulatory therapies during study or prior to entry. * medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.

Keywords: sputum conversion liver biochemistry weight loss quality of life
efficacy and safety of digital therapeutic in adults with prediabetes

Conditions: PreDiabetes

Summary: the study aims to evaluate the efficacy and safety of a digital therapeutic (th-001) for adult individuals with prediabetes.


Eligibility criteria:
inclusion criteria: * being diagnosed with prediabetes according to the ada prediabetes diagnostic criteria (the presence of at least one of the following criteria is sufficient for diagnosis: fbg 100 - 125 mg/dl, ogtt 2 hour bg: 140 - 199 mg/dl, hba1c: 5.7% - 6.4) * not using medication for the treatment of prediabetes, and if so, taking a break for at least two weeks * having a smartphone with an ios or android operating system * being able to use a mobile application exclusion criteria: * being diagnosed with diabetes mellitus * having a disease that can cause prediabetes * taking medication that may cause prediabetes

Keywords: prediabetic state digital therapeutic mobile health digital health mobile apps lifestyle modification mhealth
a randomized, double-blind, placebo-controlled trial on efficacy and safety of fluticasone propionate/albuterol sulfate combination in participants 12 years and older with asthma

Conditions: Asthma

Summary: the primary objective of the trial is to evaluate the efficacy of fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module (fp/abs emdpi). secondary objectives are: * to evaluate the efficacy of fp/abs emdpi administered four times daily * to evaluate the safety and tolerability of fp/abs emdpi administered four times daily over four weeks * to investigate the pharmacokinetics of fp/abs emdpi, abs emdpi and fp emdpi after administration of a single dose the planned study duration for each participant is approximately 10 weeks, excluding an optional prescreening visit.


Eligibility criteria:
inclusion criteria: * the participant has a diagnosis of asthma of at least 6 months duration. * participants currently receive a beta-agonist (eg, salbutamol \[albuterol\] or ics albuterol or ics-formoterol) as rescue medication with or without asthma controller medication. * if female, a participant is currently not pregnant, breastfeeding, or attempting to become pregnant (for at least 30 days before the screening visit and throughout the duration of the trial), or is of non-childbearing potential. note- additional criteria apply, please contact the investigator for more information exclusion criteria: * the participant has a history of life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation, associated with hypercapnia, respiratory arrest, hypoxic seizures or an asthma related syncopal episode. * the participant has had an upper or lower respiratory tract infection within 2 weeks or has had a confirmed case of covid-19 within 6 weeks prior to visit 1. symptoms of the infection(s) must be completely resolved prior to entering screening. * the participant is a current smoker and/or has a history of ≥10 pack years history of smoking. a current smoker is defined as any participant who has used any form of tobacco product (including oral) within the past 6 months, or any orally inhaled products including but not limited to cigarettes, beedis, vaping/ e-cigarettes, hookah/waterpipes, or marijuana. note: participants with a positive urinary cotinine test will be excluded. * the participant has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease (copd), chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, pulmonary fibrosis), or participants with a diagnosis of asthma copd overlap syndrome. note- additional criteria apply, please contact the investigator for more information
active-controlled study to assess the efficacy and safety of dfd-05 in subjects with common warts

Conditions: Common Warts

Summary: dfd05 vs. active01 in the treatment of common warts


Eligibility criteria:
inclusion criteria: 1. subjects, any gender or race, must be in good general health as determined by the investigator with a clinical diagnosis of common warts. 2. subjects must have at least 1 visible, discrete, common wart with at least a 3 mm longitudinal diameter on the hands, feet (excluding soles) and palms (in that order of priority). 3. the warts must have been present for at least the past 12 weeks, but not more than 3 years 4. subjects must agree to only use the study products and to not use any other wart-removing product (prescription, otc or occlusion) during the course of the study. 5. subjects must be free of any systemic or dermatologic disorder, which in the opinion of the investigator, will interfere with the study results. 6. female subjects of childbearing potential must agree to use contraception during the study. all women of childbearing potential must have a negative urine pregnancy test at screening and baseline and at 4, 8 \& 12 weeks visits. 7. subjects are physically able to apply study product to all affected areas or can obtain help. exclusion criteria: 1. women who are pregnant or nursing or planning to become pregnant during the study. 2. subjects who have been treated for warts within the 30 days prior to the baseline visit (e.g. salicylic acid, azelaic acid, cryotherapy). 3. subjects who have participated in a trial involving any investigational product in the 30 days prior to the baseline visit. 4. subjects with chronic or active liver disease, renal impairment, cutaneous or systemic lupus erythematosus, an autoimmune disorder, immunosuppression, or any other disease or medical condition that would interfere with the study or place the subject at unacceptable risk, as determined by the investigator. 5. subjects on immunosuppressive agents that would impact their immune response e.g. cyclosporine, mycophenolate mofetil, azathioprine, etc. 6. subjects who use or have used local/systemic steroids or any other immunosuppressive medication within the 30 days prior to the baseline visit. 7. subjects who use or have used systemic or topical retinoids within the 30 days prior to the baseline visit. 8. subjects who are unable to comply with study requirements. 9. subjects with other skin diseases like molluscum contagiosum that may confound the evaluation of common warts. 10. subjects who have received treatment for any type of cancer within 5 years of the baseline visit, except skin cancer and cervical cancer (in situ) are allowed if at least 1 year before the baseline visit. 11. subjects unable to comply with study requirements
post-operative intravenous iron to treat iron-deficiency anemia in patients undergoing cardiac surgery

Conditions: Chronic Iron Deficiency Anaemia; Cardiac Surgery

Summary: poam is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in canada. the study is designed to assess the feasibility of a future, definitive rct investigating whether, in patients with chronic iron-deficiency anemia undergoing cardiac surgery, iv iron therapy in the postoperative period (initiated shortly after surgery, and repeated at 42 days after surgery, if needed) improves clinical outcomes (days alive and out of hospital at 90 days after surgery; daoh-90) relative to placebo.


Eligibility criteria:
inclusion criteria: patients who are undergoing any non-emergency cardiac surgery with cardiopulmonary bypass (cpb) and who meet all following criteria: 1. age greater than 18 years old 2. preoperative iron-deficiency with or without anemia (defined as hb \<130 g/l) with any one of: 1. ferritin ≤ 300 μg/l and transferrin saturation ≤ 20%; or 2. reticulocyte hb content \< 29 pg, where available exclusion criteria: patients who meet any of the following criteria are not eligible for the study: 1. specialized procedures (e.g., ventricular assist device insertion, thoracoabdominal aneurysm, complex adult congenital surgery and heart transplant) 2. established contraindications to iv iron: 1. hypersensitivity to the iron product 2. history of \>2 food and/or drug allergic reactions (excluding drug intolerance) 3. non-iron deficiency anemias such as myelodysplastic syndrome 4. history of iron overload or disturbances in use of iron such as hemochromatosis or hemosiderosis 5. decompensated liver cirrhosis (meld ≥ 19) or active hepatitis 6. active infection 3. preoperative unstable hemodynamics defined as the requirement for vasopressors or inotropes, or active bleeding (as noted in the clinical record and/or defined as a requirement for red blood cell transfusion for ongoing clinical bleeding) 4. refusal of blood products for religious or other reasons 5. known pregnancy 6. already enrolled in this trial 7. enrolment in another interventional trial which may impact anemia or transfusion management (for example, a trial of hemostatic therapies, such as tranexamic acid) 8. receipt of intravenous iron at any point in the 6 weeks prior to randomization

Keywords: ferric derisomaltose (monoferric) intravenous iron
a phase i/ii clinical study of wf 10 iv solution ( tcdo ) in patients with hiv infection

Conditions: HIV Infections

Summary: to evaluate the clinical toxicity, safety, and mtd of wf 10 ( tcdo ) intravenous solution administered to patients with hiv infection. to evaluate the potential anti-hiv activity of tcdo.


Eligibility criteria:
inclusion criteria concurrent medication: required: * aerosolized pentamidine (300 mg monthly) as prophylaxis for pcp only in patients with cd4 count \<= 200 cells/mm3. allowed: * pcp prophylaxis with aerosolized pentamidine in patients with cd4 count \> 200 cells/mm3, only at the discretion of the treating physician. patients must have: * hiv positivity. * absolute cd4 count of 150 - 500 cells/mm3. * at least 6 months of prior zidovudine therapy. * no active opportunistic infection requiring ongoing therapy. * life expectancy of at least 6 months. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * neoplasm other than basal cell carcinoma of the skin. * clinically significant cardiac disease. * abnormal neurological status by a standardized assessment including strength, reflex testing, and sensory testing. * unwilling to comply with protocol requirements. patients with the following prior conditions are excluded: history of myocardial infarction or arrhythmias. prior medication: excluded within 2 weeks prior to study entry: * antiretroviral agent or interferon. * systemic biologic response modifiers, corticosteroids, cytotoxic chemotherapeutic agents, or other drugs that can cause neutropenia or significant nephrotoxicity. * rifampin or rifampin derivatives. * systemic anti-infectives. required: * at least 6 months of prior zidovudine. active drug or alcohol abuse.

Keywords: acquired immunodeficiency syndrome aids-related complex antiviral agents
electrical signal collection from a 20 pole catheter during routine cardiac procedures

Conditions: Cardiac Arrhythmias

Summary: routine data collection will be conducted during normal sinus rhythm and av synchronous pacing for approximately 20 minutes. the data collected will then be processed and the p, r and t wave amplitudes will be measured.

the purpose of this study is to collect atrio-ventricular electrograms using a sequence of tip-ring spacings in patients undergoing routine cardiac procedures (ep study, pacemaker/icd/crt implant). to collect these signals, a 20 pole catheter (medtronic stablemapr intracardiac steerable electrode catheter) will be acutely placed in the rv apex during a routine cardiac procedure. routine data collection will be conducted during normal sinus rhythm and av synchronous pacing for approximately 20 minutes. the data collected will then be processed and the p, r and t wave amplitudes will be measured.

Eligibility criteria:
inclusion criteria: * subjects aged 18 or above, or of legal age to give consent specific to the national law of the countries in which the study is being conducted * subjects who are undergoing a cardiac procedure where routine placement of cardiac catheter can be performed * subjects are willing to provide informed consent exclusion criteria: * • subject has exclusion criteria per local law and regulations (e.g. age, breast feeding, etc) * any condition which precludes the subject's ability to comply with the study requirements * subject has physical conditions that contraindicate the use of the device per approved labeling, including but not limited to active sepsis, known sensitivity to heparin, cannot undergo standard anticoagulation protocol for cardiac procedure, blood clotting abnormalities or a recent coagulopathy or embolic event, venous filtering device (greenfield filter) and obstructed or damaged vessel
dual integrin αvβ3 and grpr targeting pet imaging in breast cancer patients

Conditions: Breast Cancer

Summary: this is an open-label positron emission tomography/computed tomography (pet/ct) study to investigate the diagnostic performance and evaluation efficacy of 68ga-nota-bbn-rgd in breast cancer patients. a single dose of 111-148 mega-becquerel (mbq) 68ga-nota-bbn-rgd will be injected intravenously. visual and semiquantitative method will be used to assess the pet/ct images.

gastrin-releasing peptide receptor (grpr) is a member of the g protein-coupled receptor family of bombesin receptors, which is over-expressed in various types of cancer cells, including prostate cancer, breast cancer, colorectal cancer, pancreatic cancer, glioma, lung cancer, ovarian cancers, endometrial cancers, renal cell cancer and gastrointestinal stromal tumors. bbn(7-14), with the amino acid sequence of gln-trp-ala-val-gly-his-leu-met-nh2, has been extensively used for the development of molecular probes for the imaging of grpr. on the other hand, the rgd moiety binds with integrin αvβ3 receptor, also plays an important role in the regulation of tumor growth, angiogenesis, local invasiveness, and metastatic potential in human breast cancer. to target both receptors, a heterodimeric peptide bbn-rgd was synthesized from bombesin(7-14) and c(rgdyk) through a glutamate linker and then labeled with 68ga. an open-label whole-body pet/ ct study was designed to investigate the safety and dosimetry of 68ga-nota-bbn-rgd and diagnostic performance of 68ga-nota-bbn-rgd pet/ct in breast cancer patients.

Eligibility criteria:
inclusion criteria: * neoplasm identified by x-ray, ultrasound or mri as breast cancer * to provide basic information and sign the written informed consent. exclusion criteria: * consisted of conditions of mental illness; * severe liver or kidney disease with serum creatinine \> 3.0 mg/dl (270 μμ) or any hepatic enzyme level 5 times or more than normal upper limit; * severe allergy or hypersensitivity to iv radiographic contrast * claustrophobia to accept the pet/ct scanning * pregnancy or breast feeding

Keywords: bbn-rgd grpr integrin αvβ3
recombinant human antithrombin (atryn®) in the treatment of patients with dic associated with severe sepsis

Conditions: Disseminated Intravascular Coagulation

Summary: the primary objective of the study is to explore the efficacy and safety of atryn® (antithrombin alfa) for the treatment of disseminated intravascular coagulation (dic) associated with severe sepsis, when administered by continuous intravenous (iv) infusion over five days.


Eligibility criteria:
inclusion criteria: * signed informed consent has been obtained from the patient or his/her legally acceptable representative * severe sepsis * disseminated intravascular coagulation

Keywords: dic associated with severe sepsis